Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT01217320
Status:
UNKNOWN
Last Update Posted:
2012-01-16
First Post:
2010-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Creatine Supplementation in Pediatric Rheumatology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003882', 'term': 'Dermatomyositis'}], 'ancestors': [{'id': 'D017285', 'term': 'Polymyositis'}, {'id': 'D009220', 'term': 'Myositis'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003401', 'term': 'Creatine'}, {'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-01-12', 'studyFirstSubmitDate': '2010-10-06', 'studyFirstSubmitQcDate': '2010-10-07', 'lastUpdatePostDateStruct': {'date': '2012-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'muscle strength', 'timeFrame': 'after six months'}], 'secondaryOutcomes': [{'measure': 'kidney function parameters', 'timeFrame': 'after six months'}, {'measure': 'quality of life', 'timeFrame': 'after six months'}, {'measure': 'muscle function', 'timeFrame': 'after six months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rheumatology', 'creatine supplementation', 'quality of life', 'strength', 'juvenile systemic lupus erythematosus', 'juvenile dermatomyositis'], 'conditions': ['Juvenile Systemic Lupus Erythematosus', 'Juvenile Dermatomyositis']}, 'referencesModule': {'references': [{'pmid': '25135060', 'type': 'DERIVED', 'citation': 'Hayashi AP, Solis MY, Sapienza MT, Otaduy MC, de Sa Pinto AL, Silva CA, Sallum AM, Pereira RM, Gualano B. Efficacy and safety of creatine supplementation in childhood-onset systemic lupus erythematosus: a randomized, double-blind, placebo-controlled, crossover trial. Lupus. 2014 Dec;23(14):1500-11. doi: 10.1177/0961203314546017. Epub 2014 Aug 18.'}]}, 'descriptionModule': {'briefSummary': 'Creatine supplementation may improve strength, muscle mass, bone mass and muscle function in healthy and elderly people. The investigators speculate that creatine supplementation could have therapeutic effects in pediatric rheumatic (i.e., juvenile systemic lupus erythematosus and juvenile dermatomyositis) patients who usually present muscle weakness, muscle wasting and bone mass loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients diagnosed with lupus systemic erythematosus and juvenile dermatomyositis\n* physically inactive\n* stable pharmacological treatment\n\nExclusion Criteria:\n\n* macroalbuminuria\n* GFR \\< 30 mL/min/1.73m2\n* use of oral anticontraceptive agents\n* pregnancy\n* diabetes mellitus\n* hypothyroidism'}, 'identificationModule': {'nctId': 'NCT01217320', 'briefTitle': 'Creatine Supplementation in Pediatric Rheumatology', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Efficacy and Safety of Creatine Supplementation in Patients With Juvenile Systemic Lupus Erythematosus and Juvenile Dermatomyositis', 'orgStudyIdInfo': {'id': 'Cr in rheumato'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'creatine supplementation', 'description': 'will receive 5g/d of creatine monohydrate throughout the trial', 'interventionNames': ['Dietary Supplement: creatine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'will receive 5g/d of placebo (dextrose) throughout the trial', 'interventionNames': ['Dietary Supplement: placebo (dextrose)']}], 'interventions': [{'name': 'creatine', 'type': 'DIETARY_SUPPLEMENT', 'description': '5g/d throughout 12 weeks', 'armGroupLabels': ['creatine supplementation']}, {'name': 'placebo (dextrose)', 'type': 'DIETARY_SUPPLEMENT', 'description': '5g/d throughout 12 weeks', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05508-30', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Bruno Gualano, PhD', 'role': 'CONTACT', 'email': 'gualano@usp.br'}, {'name': 'Bruno Gualano, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Bruno Gualano, PhD', 'role': 'CONTACT', 'email': 'gualano@usp.br', 'phone': '551130913096'}], 'overallOfficials': [{'name': 'Bruno Gualano, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Sao Paulo'}, {'name': 'Eloisa Bonfa, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Bruno Gualano', 'investigatorAffiliation': 'University of Sao Paulo'}}}}